Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Eosinophilic Gastroenteritis

Treatments: Other: Elemental Diet Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03320369

2017-2766

U54AI117804 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

Full description

This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant must be able to understand and provide informed consent
2. Males and Females ≥18 to 65 years of age;
3. Have diagnosis of EG/EGE
4. Have histologically confirmed active disease > 30 eosinophils/hpf
5. Symptomatic (have experienced symptoms within the last one months prior to enrollment).
6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry
7. Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study-specific methods may be listed, if applicable

Exclusion criteria

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Secondary causes of gastrointestinal and peripheral eosinophilia
3. Eosinophilic infiltration isolated to the esophagus.
4. Pregnancy
5. Immunodeficiency states
6. Have been treated with topical swallowed steroids within the last 6 weeks or systemic steroids within the last 2 months unless repeat endoscopy is performed and shows active inflammation on these therapies in which case these medications will be allowed to be continued without dose escalation.
7. Have taken immunosuppression medication or immunomodulators within 2 months of the study unless the recent/baseline endoscopy has active histologic inflammation while on these medications. In this case, these medications will be permitted to be continued as long as the dose is not escalated during the treatment phase.
8. Have been on an elemental diet previously for six weeks with follow up endoscopy completed.
9. Have participated in any investigative drug study within 6 weeks prior to study entry.
10. Unable to complete study procedures including endoscopy.
11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Treatment

Other group

Description:

Elemental formula Intervention: Elemental Diet Therapy

Treatment:

Other: Elemental Diet Therapy